# K051516: Trabecular Metal Revision Shell Liners

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Jul 27, 2005 after 49 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983128 (1998). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983128: Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy, 02-248-Xxyyy, Implex Corp. (1998) Summary page 1.

## Most influential descendants
- K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner (2008), 3 descendants of its own
- K181366: REDAPT Porous Acetabular Shell (2018), 1 descendant of its own
- K253630: Mpact 3D Metal Foam (2026), 0 descendants of its own
- K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (2025), 0 descendants of its own
- K242744: Trinity EVO Acetabular Shell (2025), 0 descendants of its own

## Indications for use
The TrabecularMetal Revision Shell Liner is indicated for cemented use in the TrabecularMetal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Source page: https://510kreport.com/device/K051516
Methodology: https://510kreport.com/methodology